Clinical and brain magnetic resonance imaging long-term follow-up in patients with cryptogenic stroke undergoing PFO closure with the NobleStitch EL system. A single-centre experience

Introduction

The NobleStitch EL system has recently been proposed as a safe and effective technique for percutaneous closure of patent fossa ovalis (PFO) in patients with cryptogenic stroke and evidence of paradoxical embolism [1]. Data on its long-term efficacy are, to date, quite scarce and limited to recurrences of clinically relevant neurological events [2]. It is unknown whether such a procedure confers protection against novel asymptomatic ischaemic lesions evaluated through appropriate brain imaging.

Aim

The present study aims to report initial results from a cohort of subjects treated with suture-mediated PFO closure for cryptogenic stroke, undergoing longitudinal clinical and instrumental follow-up by brain magnetic resonance imaging (MRI).

Material and methods

We initially screened all patients with cryptogenic stroke and PFO evaluated at the Unit of Interventional Cardiology, “Santa Maria” University Hospital, Terni, Italy, during the period between January 2018 and December 2020, who satisfied criteria for percutaneous closure. Patients with carotid or aortic atherosclerotic plaques, left-sided cardiac embolic sources, repetitive supraventricular or ventricular arrhythmias at ECG-Holter monitoring, or multi-fenestrated septum at initial echocardiography screening were excluded from the study. All the remaining patients were treated with the NobleStitch EL system and subsequently followed up. The period of observation started immediately after the percutaneous interventional procedure. Baseline pre-procedural clinical, contrast echocardiographic (LV ejection fraction, right-to-left shunt, PFO length and width, presence of atrial-septal aneurysm), and neuroimaging (brain MRI) data were collected. Echocardiographic images were acquired only in 2D modality. We used the echo-contrast mode with microbubbles to identify and quantify the right-to-left shunt before and after the intervention. All PFO closure procedures were performed by 2 operators experienced in interventional cardiology, all under local anaesthesia, through right femoral venous access, under fluoroscopic guidance. We employed iodinated contrast medium administration for a correct intra-procedural PFO anatomy evaluation and subsequent closure of the same. Following the operation, the standard of care pharmacological treatment, consisting in a single antiplatelet agent (acetylsalicylic acid or clopidogrel) was prescribed according to current position...


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